ORMALVI (dichlorphenamide) · TORRENT
ORMALVI is an oral medication used for patients with primary hyperkalemic or hypokalemic periodic paralysis. It also helps those suffering from related variants of these muscle conditions. This medication provides a therapeutic option for managing these specific types of periodic paralysis.
How ORMALVI Works
ORMALVI works by inhibiting the enzyme carbonic anhydrase. While it is classified as a carbonic anhydrase inhibitor, the exact process by which this action produces its therapeutic effects in patients with periodic paralysis is not yet known.
Details
- Status
- Prescription
- First Approved
- 2022-12-29
- Routes
- ORAL
- Dosage Forms
- TABLET
ORMALVI Approval History
What ORMALVI Treats
2 indicationsORMALVI is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperkalemic Periodic Paralysis
- Hypokalemic Periodic Paralysis
ORMALVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ORMALVI FDA Label Details
Indications & Usage
ORMALVI is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. ORMALVI is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.